Food & Drug Inspection Monitor

摘要

GSK consent decree seen as sign of renewed DOJ crackdown on drug-device corporate compliance. Human Drugs: Cardinal Health passes inspection, but blend uniformity issue noted; Greer Labs cited for investigation failures and tests not meeting current USP requirements;Ultra-Seal slapped with 6-item 483 for labeling flaws, drugs stored at wrong temperature. Medical Devices: Staar Surgical hit with 5-item 483 for complaint handling, MDR filings, acceptance activities.